"Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The me"...
Patients in clinical trials (N = 670) received single oral doses of 140 to 300 mg without significant adverse reactions. Volunteers (N = 174) received single oral doses of 140 to 400 mg without serious adverse reactions.
Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.
The elimination half-life of sumatriptan is approximately 2.5 hours [see CLINICAL PHARMACOLOGY], and therefore monitoring of patients after overdose with IMITREX Tablets should continue for at least 12 hours or while symptoms or signs persist.
It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.
IMITREX Tablets are contraindicated in patients with:
- Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina [see WARNINGS AND PRECAUTIONS]
- Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see WARNINGS AND PRECAUTIONS]
- History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see WARNINGS AND PRECAUTIONS]
- Peripheral vascular disease [see WARNINGS AND PRECAUTIONS]
- Ischemic bowel disease [see WARNINGS AND PRECAUTIONS]
- Uncontrolled hypertension [see WARNINGS AND PRECAUTIONS]
- Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agoni st [see DRUG INTERACTIONS]
- Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY]
- Hypersensitivity to IMITREX (angioedema and anaphylaxis seen) [see WARNINGS AND PRECAUTIONS]
- Severe hepatic impairment [see Use in Specific Populations and CLINICAL PHARMACOLOGY]
Last reviewed on RxList: 12/9/2013
This monograph has been modified to include the generic and brand name in many instances.
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